Kornimate/medical-research-clean huggingface dataset:
somatic-psychosocial care concept for oncologic patients undergoing hematopoietic stem cell transplantation (hsct)

Conditions: Oral Mucositis; Malnutrition

Summary: this study will test the scion (self care improvement through oncology nursing)-hsct program a multi-modular, somatic-psycho-social care intervention to improve self management in oncologic patients undergoing hsct. the study will determine if the self management skills of the patients to enhance: * physical activity, * prevention of oral mucositis and * mal nutrition during the period of hospitalization. it is hypothesized that patients who receive the multi-modular somatic-psycho-social care intervention will have better health related quality of life (hrqol).

according to precede model of health behavior from green - modified by our research group - patients self management skills are affected by the patients' knowledge, activities and attitude to self management. therefore, we propose a prospective non-randomized clinical trial that will test the effectiveness of scion-hsct program against care as usual on perceived hrqol of the patient and the adherence to care program. oncology patients with hsct will be recruited by the nurses of the participating wards under the guidance of a research nurse. they will be included in the trial if they will meet the inclusion criteria and signed informed consent (the full inclusion criteria see below). groups will be treated consecutively. the first group will receive care as usual (control). after finishing the control period, i.e. after 42 patients will have completed the trial. the the newly assigned patients will be treated according to scion-hsct program a multi-modular somatic-psycho-social care intervention (intervention). the intervention will be conducted by specially trained ward nurses in cooperation with the research nurse. it includes components of knowledge, skills training, and coaching to improve patients adherence to self management strategies for physical activity, prevention of oral mucositis and mal nutrition prevention. the hrqol, adherence and symptom level of the patients will be observed up to 100 days post hsct. both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.

Eligibility criteria:
inclusion criteria: * hematologic patients (\> 14 years of age) * hematological stem cell transplantation (hsct) allogenic or autologous * informed consent exclusion criteria: * unable to read, write, and understand german

Keywords: self management adherence activity enhancement oral mucositis prevention and mal nutrition prevention cancer hematopoietic stem cell transplantation (hsct) loss of activity
open lung strategy in critically ill morbid obese patients

Conditions: Obesity; Respiratory Insufficiency; Right-Sided Heart Failure; Pulmonary Atelectasis; Respiratory Mechanics

Summary: the goal of this interventional crossover study in morbidly obese intubated and mechanically ventilated patients is to describe the respiratory mechanics and the heart-lung interaction at titrated positive end-expiratory pressure levels following a recruitment maneuver with transthoracic echocardiography and electric impedance tomography imaging.

obese patients under mechanical ventilation are more likely to develop atelectasis as a consequence of the increased abdominal weight. atelectasis is the primary responsible for respiratory insufficiency and impossibility to wean obese patients from respiratory support. in a previous study we demonstrated the efficacy of the application of titrated peep levels following a recruitment maneuver in obese patients, i.e. improvement in respiratory mechanics and gas exchanges without negative hemodynamic effects. the application of lung and heat imaging will allow us to quantitatively describe: * increase in aerated lung tissue (reduction of atelectasis) * reduction of over-inflation of the ventilated regions * recoupling of ventilation and perfusion * improvement in right heart function by reduction of right heart afterload

Eligibility criteria:
inclusion criteria: * icu admitted requiring intubation and mechanical ventilation * bmi ≥ 35 kg/m2 * waist circumference \> 88 cm (for women) * waist circumference \> 102 cm (for men) exclusion criteria: * known presence of esophageal varices * recent esophageal trauma or surgery * severe thrombocytopenia (platelets count ≤ 5,000/mm3) * severe coagulopathy (inr ≥ 4) * presence or history of pneumothorax * pregnancy * patients with poor oxygenation index (pao2/fio2\< 100 mmhg with at least 10 cmh2o of peep) * pacemaker and/or internal cardiac defibrillator * hemodynamic parameters: systolic blood pressure (sbp) \ 180 mmhg, or if sbp is between 100-180 mmhg on high dose of iv continuous infusion norepinephrine (\>20 μg per minute), or dobutamine (\>10 μg per minute), or dopamine (\>10 μg per kg per minute), or epinephrine (\>10 μg per minute).
effect of herbs and spices on metabolic regulation and appetite in healthy subjects

Conditions: Healthy

Summary: the purpose of the study is to investigate how herbs and spices affect acute/postprandial glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative capacity, as well as subjective appetite ratings (vas-visual analogue scales) in healthy volunteers. we hypothesize that certain herbs and spices added to a standardized meal will improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers, compared with a similar meal without the corresponding plant materials.

the aims of the study is to investigate whether consumption of preload isovolumetric (220 ml) spice-based beverages contained total polyphenol concentration to 185 mg gallic-acid equivalents followed by white wheat bread challenge (contained 50 g available carbohydrate) might affect postprandial glucose metabolism, inflammatory markers, appetite-related gut hormones, plasma antioxidant capacity, as well as appetite sensations in healthy subjects.

Eligibility criteria:
inclusion criteria: * healthy males and females * signed informed consent * bmi 20 - 28 kg/m2 with weight change \<3 kg latest 2 months) * must be able to accept herbs and spices exclusion criteria: * below 18 years * uncomfortable speaking english and/or difficulties in understanding spoken english * smoking or using snuff * vegetarian or vegan * stressed by venous blood sampling or previous experience of being difficult to cannulate * receiving any drug treatment that may influence the study outcomes * pregnancy or breastfeeding

Keywords: spices herbs functional food cardiometabolic risk metabolic syndrome inflammation appetite gut hormone
randomised controlled trial of the efficacy of acupuncture versus placebo on the caesarean section rate in case of cervical dystocia in full-term pregnancy

Conditions: Cervical Dystocia

Summary: the principal objective of the trial is to demonstrate that acupuncture could reduce the caesarean section rate for cervical dystocia. secondary objectives: to demonstrate that acupuncture can: * reduce morbidity, fetal mortality and duration of childbirth; * reduce the cost of care, due to diminution of caesarean sections and duration of obstetric labor; * to evaluate the tolerance.

in this trial, pregnant women with at least 37 weeks of amenorrhea will be randomized to traditional chinese acupuncture, sham acupuncture, or usual care only. 9 investigator sites will participate to this trial targeting to enrol 2220 patients in total. 1780 subjects will receive acupuncture treatment, either effective treatment or sham, whereas 400 patients will receive usual care only. acupuncture therapy consists in stimulations on specific skin points of the abdominal area, which are specific acupuncture points in traditional chinese medicine for the induction of obstetric labor, according to the professional recommendations of the french acupuncture and traditional chinese medicine college. each patient will have a 5-week follow-up in this trial.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * signed informed consent * woman carrying one foetus only * at 37 weeks (+/- 2 days) of amenorrhea * without contraindication to vaginal delivery exclusion criteria: * prior history of caesarean section * non-cephalic presentation * fetal macrosomia * multiple pregnancy * chronic fetal hypoxia * placenta praevia * risk of neonatal contamination

Keywords: acupuncture cervical dystocia caesarean section obstetric labor randomized controlled trial
research on the relationship between cognitive function changes and cerebrovascular health in patients with coronary heart disease

Conditions: Coronary Heart Disease; Image

Summary: the purpose of this study is to elucidate the imaging mechanisms of cognitive function changes in patients with coronary heart disease before and after surgery or conservative treatment, and to evaluate and predict the postoperative neurological function recovery and cerebrovascular health level of patients by combining serum markers and patient cardiovascular health evaluation indicators.

the focus of this study is to elucidate the impact of coronary heart disease on the morphology and cognitive changes of cerebral blood vessels in patients. record imaging data, neuropsychological cognitive scales, serum markers, adverse cardiac events, and patient evaluation indicators before and after clinical treatment and follow-up period, and explore relevant factors affecting changes in cerebrovascular morphology and cognitive function.

Eligibility criteria:
inclusion criteria: * confirmed coronary heart disease or risk of coronary heart disease through clinical testing * conscious and capable of completing neuropsychological scales exclusion criteria: * patients with other serious heart diseases (such as aortic aneurysm) * people with uncontrolled hypertension or diabetes * there are contraindications to mri examination (there are metal implants in the body, such as cardiac pacemakers, metal dentures, artificial joints, non paramagnetism stents, etc.; there is claustrophobia) * have a history of severe stroke, epilepsy, traumatic brain injury, and transient ischemic events * existence of neurological and mental disorders (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis, etc * have a history of alcohol or drug abuse * those with significant organ dysfunction such as lung, liver, and kidney; * patients with tumor, infectious diseases, blood system disease and immune system disease; * currently participating in other clinical studies at the same time.

Keywords: coronary heart disease mri imaging neuropsychological assessment
a self-assessment intervention for young adult polydrug users at risk for hiv

Conditions: HIV Infection; Substance Abuse

Summary: the proposed study is a three-armed randomized clinical trial. a total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, hiv pretest counseling and test administration, and collection of baseline risk behavior data. outcomes will be measured at 3, 6 and 12 months.

the specific aims of the 5-year study are to: 1. identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in miami, florida. 2. evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups: * arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (capi intervention) similar to the baseline instrument used in the parent grant; * arm 2, an identical self-administered comprehensive assessment intervention (acasi intervention); and * arm 3, a waitlist control condition (control). outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups. 3. conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.

Eligibility criteria:
inclusion criteria: * heterosexually active * ongoing club and prescription drug use * between 18-39 years of age * must go to local clubs at least two times per month exclusion criteria: * no current working phone number or e-mail address * no intention to remain in south florida for the next 12 months * new hiv diagnosis in the past 90 days * currently participating in a drug treatment program (excluding 12-step programs such as alcoholics anonymous)

Keywords: hiv/aids substance use club drugs sexual risk
car19bcma car-t cells for the treatment of r/r plasma cell neoplasms

Conditions: Relapsed or Refractory Plasma Cell Neoplasms

Summary: this is a single arm study to evaluate the safety and efficacy of car19bcma car-t cells in the treatment of relapsed/refractory cd19/bcma positive plasma cell neoplasms.

this study is an exploratory clinical trial of a single-arm, open, single-center treatment of car19bcma car-t cell. 20 subjects with relapsed or refractory cd19/ bcma positive positive plasma cell neoplasms will be enrolled and received car19bcma car t cells injection therapy, and related data such as adverse reactions and therapeutic effects after medication were followed up. to evaluate its safety and efficacy.

Eligibility criteria:
inclusion criteria: relapsed/refractory cd19bcma positive plasma cell neoplasms must be assured and meet all of the following conditions: ①confirmation for either bcma or cd19 positivity using immunohistochemistry or flow cytometry. ②patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-cd38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse. ③patients with system light chain amyloidosis who have received at least 2 lines treatments in the past \[anti-cd38 monoclonal antibody, proteasome inhibitor (pi), or immunomodulatory drug (imid)\], but have failed or experienced relapse. age 18-80 years, no gender restrictions; ecog score ≤ 2 points; expected survival period is not less than 3 months; hgb≥60g/l; liver function and cardiopulmonary function meet the following requirements: (1) left ventricular ejection fraction≥50%; (2) oxygen saturation \>90%; (3)total bilirubin ≤1.5×uln, alt and ast≤2.5×uln; participants agreed to use contraception from the time of informed consent until 1 year after car-t cell infusion. exclusion criteria: severe heart failure with left ventricular ejection fraction \<50%; a history of severe lung function impairment; combined with other advanced malignant tumors; complicated with severe infection that could not be effectively controlled; severe autoimmune disease or congenital immune deficiency; active hepatitis (hepatitis b virus dna \[hbv-dna\] or hepatitis c virus rna \[hcv-rna\] test results above the lower limit of detection); human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids), or syphilis infection; history of severe allergy to biological products (including antibiotics); patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study. female patients (those with fertility) are in pregnancy or lactation.

Keywords: car-t plasma cell neoplasms cd19/bcma
multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis (study p06332)

Conditions: Rhinitis, Allergic, Perennial

Summary: this is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (mf) in pediatric subjects with perennial allergic rhinitis. the subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. following the observation period, eligible subjects will be randomized to mf or mf placebo for a 2-week double-blind treatment. at each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (aes), will be evaluated. a 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (saes) and trial procedure-related aes.


Eligibility criteria:
inclusion criteria: * pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria: * subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period. * subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen). * male or female outpatients aged 5 to 15 years at the time of providing informed consent. exclusion criteria: * subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study. * subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration * subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics * subjects with repeated epistaxis * subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed * subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor * subjects with complication of vasomotor rhinitis or eosinophilic rhinitis. * subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
cervical sympathetic block in patients with cerebral vasospasm

Conditions: Anesthesia, Local; Cerebral Vasospasm; Subarachnoid Hemorrhage, Aneurysmal

Summary: the purposes of this study are twofold: 1) to assess the effect of a cervical sympathetic block on cerebral blood flow in patients suffering from cerebral vasospasm, after aneurysmal subarachnoid hemorrhage; 2) to evaluate the effect of the sympathetic block on the recovery of the neurological function.

patients hospitalized in the intensive care unit (icu) and developing clinical manifestations of cerebral vasospasm will undergo a computerized tomography (ct) angiography and a ct perfusion scan. if the vasospasm will be confirmed by the ct imaging, a cervical sympathetic nerve block under ultrasound guidance will be performed. the block consists in the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. a periganglionar catheter will be left in place. a ct angiography and ct perfusion will be repeated to check the effect of the block on the brain vasculature after the block is done. patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the icu.

Eligibility criteria:
inclusion criteria: * ages 18 and over * patients hospitalized in the icu and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage exclusion criteria: - known advanced stage kidney disease

Keywords: regional anesthesia cervical sympathectomy cerebral blood flow
effectiveness of melatonin for sleep disturbances in children with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: sleep disturbance is a common complaint among patients with atopic dermatitis(ad). melatonin may aid sleep and also has anti-inflammatory properties, and has been suggested in managing sleep disturbance in ad patients. however, there has been no large randomized controlled trials. hence the objective of this double-blind randomized controlled study is to determine whether supplementing melatonin is effective in improving sleep problems in children with ad.


Eligibility criteria:
inclusion criteria: * children between 1 and 18 years of age with mild to moderate ad, affecting at least 5% of total body surface area, and with sleep problems in the previous 3 months exclusion criteria: 1. those who had failed other systemic and/or topical immunosuppressive agents such as tacrolimus, methotrexate, or cyclosporine 2. those who had received therapy for insomnia within 4 weeks before the baseline visit 3. those who were, in the opinion of the investigator, known to be unreliable or noncompliant with medical treatment or appointments 4. those who had drug abuse problems, mental health dysfunction, or other factors limiting their ability to cooperate fully 5. those who were taking antihistamines, oral immunosuppressant medication, or antidepressant medication 6. pregnant and lactating women and those who are presently planning to get pregnant 7. those who had any other condition or earlier/current treatment which, in the opinion of the investigator, would render the participant ineligible for the study

Keywords: atopic dermatitis eczema